Pharmion Submits European Marketing Authorization Application (MAA) for Vidaza(R) in Patients with Higher-Risk Myelodysplastic Syndr...(an Orphan Medicinal Product in the EU fo...),Health

Date:1/14/2008

an Orphan Medicinal Product in the EU for the treatment of MDS, which, if approved, entitles the drug to ten years of market exclusivity for the approved indication. Vidaza has also been designated as an Orphan Medicinal Product in the EU for the treatment of acute myeloid leukemia (AML).

The application is based upon clinical data which includes the results from the Company's Phase 3 multi-center, international, randomized study of Vidaza(R) (azacitidine for injection) in the treatment of patients with higher-risk MDS. The primary objective of this Phase 3 trial was to demonstrate superiority in overall survival of Vidaza versus CCR. The study included 358 patients at sites in the U.S., Europe, and Australia. At baseline, approximately 90 percent of patients were considered to have higher- risk MDS, based on subsequent independent review of FAB subtypes or IPSS classification. Patients were assigned to treatment with Vidaza (N=179; 75 mg/m2/day SC for seven consecutive days every 28 days) or CCR. Patients assigned to CCR could receive either BSC alone (N=105), low-dose cytarabine (LDAC; N=49), or standard chemotherapy (Std Chemo; N=25). The median number of cycles for Vidaza was nine; the median number of cycles for the CCR arm was as follows: BSC seven cycles, LDAC 4.5 cycles and Std Chemo one cycle.

With a median follow-up of 21.1 months, Vidaza demonstrated a statistically significant overall survival advantage over CCR (24.4 months vs. 15 months; stratified log rank p=0.0001).The hazard ratio describing this treatment effect was 0.58 (95 percent confidence interval of 0.43 to 0.77). At two years, Vidaza demonstrated a two-fold advantage in overall survival over CCR (51 percent vs. 26 percent; log rank p<0.0001). Among patients with poor cytogenetic profiles (as defined by IPSS, 28 percent of enrolled patients), median survival was 17.2 months in the Vidaza arm, compared to six months in the CCR arm (log rank p=0.01). Forty-five percent of transfu
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